PHARMACY

Mylan challenges Cephalon, Eurand patent on Amrix muscle relaxant

BY Alaric DeArment

PHILADELPHIA Mylan has challenged Cephalon and Eurand’s patent on the skeletal muscle relaxant drug Amrix, Cephalon and Eurand said Tuesday.

Mylan submitted an approval application to the Food and Drug Administration for the 15 mg and 30 mg strengths of Amrix (cyclobenzaprine hydrochloride), saying that Eurand’s ‘793 patent on the drug is invalid and unenforceable or that a generic version won’t infringe on the patent. Eurand’s patent covers extended-release formulations containing cyclobenzaprine and expires in February 2025. Cephalon has a three-year period of marketing exclusivity for the drug that ends in 2010.

The two companies are reviewing the FDA’s notice letter.

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FDA approves Teva application for fentanyl patch

BY Alaric DeArment

JERUSALEM The Food and Drug Administration has approved Teva’s application for its fentanyl transdermal system, the Israeli drug maker announced Monday.

The patches, which will deliver the medication at rates of 25 to 100 micrograms per hour for treating pain, are a generic equivalent to Johnson & Johnson’s Duragesic patches.

Combined sales of the branded and generic versions of the drug were $1.2 billion during the 12 months ending June 30, according to IMS Health data.

Teva said shipment of the patches had begun already.

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Medicaid cost hikes ‘unsustainable,’ HHS secretary warns state budgeters

BY Jim Frederick

WASHINGTON Spending for Medicaid is rising to “unsustainable” levels, and the program’s rapidly rising costs are threatening access to health care for poor and lower-income Americans, Health & Human Services Secretary Mike Leavitt warned Friday.

The U.S. Centers for Medicare & Medicaid Services is projecting that the Medicaid program will spend $4.9 trillion over the next 10 years. That marks an average annual increase of 7.9 percent annually, according to federal budgeters, significantly outpacing the U.S. economy’s growth rate.

CMS released its report Friday, prompting a grim warning from the HHS secretary at a meeting of state budget directors. “This report should serve as an urgent reminder that the current path of Medicaid spending is unsustainable for both federal and state governments,” Leavitt said. “If nothing is done to rein in these costs, access to healthcare for the nation’s most vulnerable citizens could be threatened.”

Combined, Medicaid and Medicare are expected to gobble up 6.9 percent of the gross domestic product by 2017 at current growth rates, according to HHS. This year, Medicaid will see its rolls swell to a projected 50 million beneficiaries, at an average annual cost per person of more than $6,100.

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